LULMITEX NEONATAL TRANSILLUMINATOR
FDA 510(k) clearance K912747 · decided 1991-12-24
Clearance details
- K-number
- K912747
- Device name
- LULMITEX NEONATAL TRANSILLUMINATOR
- Applicant
- Lumitex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-21
- Decision date
- 1991-12-24
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- HJN
- Device class
- 1
- Regulation number
- 886.1945
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VENOSCOPE (K941035) | Trinity Partners, LLC | 1994-05-16 |
| SYLVAN PEDIASCAN 200 TRANSILLUMINATOR (K901309) | Sylvan Corp. | 1990-05-24 |
Recalls involving this device
No recalls on record reference this clearance.